ASTM E2935 - 21
Standard Practice for Evaluating Equivalence of Two Testing Processes
| Aviso: | Las normas ASTM en lectura se visualizan a través del área de cliente. Los archivos no se pueden descargar |
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| Fecha edición: |
2021-06-01
Anulada
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| Fecha cancelación: | 2021-06-01 |
| Idiomas disponibles: | Inglés |
| Resumen: | This practice provides statistical methodology for conducting equivalence testing on numerical data from two sources to determine if their true means or variances differ by no more than predetermined limits. This standard provides guidance on experiments and statistical methods needed to demonstrate that the test results from a modified testing process are equivalent to those from the current testing process, where equivalence is defined as agreement within a prescribed limit, termed an equivalence limit. |
| Keywords: | bias equivalence; confidence interval; equivalence; equivalence limit; error-in-variables regression; means equivalence; non-inferiority; orthogonal least squares; range equivalence; slope equivalence; two one-sided tests (TOST) procedure; |
| Scope: | 1.1 This practice provides statistical methodology for conducting equivalence studies on numerical data from two sources of test results to determine if their true means, variances, or other parameters differ by no more than predetermined limits. 1.2 Applications include (1) equivalence studies for bias against an accepted reference value, (2) determining means equivalence of two test methods, test apparatus, instruments, reagent sources, or operators within a laboratory or equivalence of two laboratories in a method transfer, and (3) determining non-inferiority of a modified test procedure versus a current test procedure with respect to a performance characteristic. 1.3 The guidance in this standard applies to experiments conducted either on a single material at a given level of the test result or on multiple materials covering a selected range of test results. 1.4 Guidance is given for determining the amount of data required for an equivalence study. The control of risks associated with the equivalence decision is discussed. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. |
| ICS: | 03.120.30 - Aplicación de métodos estadísticos |
| CTN: | E11.20 - E11.20 |
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Otras Relaciones |
Es referenciada por D4218-20 Es referenciada por D4883-18 Es referenciada por D2396-20 Es referenciada por D0955-21 Es referenciada por D6437-22 Es referenciada por D1790-21 Es referenciada por D2457-21 Es referenciada por D5227-21 Es referenciada por D6576-20 Es referenciada por D3768-22 Es referenciada por D4889-21 Es referenciada por D7253-22 Es referenciada por D3575-20 Es referenciada por D1622-20 Es referenciada por D5507-21A Es referenciada por D1603-20 Es referenciada por D4671-21 Es referenciada por D1056-20 Es referenciada por D1004-21 Es referenciada por D5420-21 |
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